中文摘要：

目的观察干燥综合征（Sjogren syndrome,SS）患者凝血参数及细胞因子、NF-кB信号通路蛋白、实验室指标的变化,探讨新风胶囊（Xinfeng Capsule,XFC）改善SS患者高凝状态的机制。方法将66例SS患者随机分为研究组和对照组各33例,分别予XFC和硫酸羟氯喹（Hydroxychloroquine,HCQ）治疗。另选20名健康者作为正常对照组。酶联免疫吸附法检测IL-4、IL-1β、TNF-α、IL-10、p65、p50、IκBα;实时荧光定量检测p65、p50、IκBαm RNA表达量,免疫印迹法检测p65、p50蛋白表达;并测定凝血指标及相关实验室指标。结果与NC组比较,SS组D-D、FIB明显升高,唾液流率、泪膜破裂时间及IL-4、IL-10表达明显降低,角膜染色评分及IL-1β、TNF-α、P50、P65、IκBα、hs-CRP、ESR显著升高（P〈0.05或P〈0.01）;相关性显示SS患者的凝血指标与细胞因子、NF-κB通路以及临床症状体征、疾病活动性指标等呈明显相关性;药物干预后,2组凝血参数、临床症状和实验室指标均有所改善;与HCQ组比较,XFC组有效率和总有效率显著高于HCQ组,且在改善患者静态唾液流率、泪膜破裂时间、双眼染色评分,降低FIB、D-D、P50、P65,ESR、Hs-CRP水平,上调TNF-α、IL-1β,下调IL-4、IL-10方面明显优于HCQ组（P〈0.05或P〈0.01）。结论 XFC可通过平衡细胞因子的表达,抑制NF-κB信号通路的活化,降低对血管内皮细胞的损伤,从而改善SS患者高凝状态。

英文摘要：

To explore the mechanism underlying improving effect of Xinfeng Capsule（XFC） onhypercoagulable state in Sjogren＇s syndrome（SS） patients, we observed the changes in coagulation parameters,peripheral blood cytokines, NF-kappa B signaling pathway protein, laboratory indexes of SS patients. The studyenrolled 66 SS patients and divided them randomly into 2 groups： treatment group and control group（n=33 in everygroup）. The treatment group was given XFC, while the control group was treated with hydroxychloroquine（HCQ）,and other 20 healthy people were included as a normal control group（NC）. The m RNA expression of p65, p50, and I·Bα were detected using real time fluorescent quantitative PCR; Western blot was employed to detect the proteinlevels of p50 and p65. Furthermore, the levels of the coagulation related indicators were also observed. We foundthat the coagulation parameters D-D and FIB, the corneal fluorescein staining scores, the cytokines IL-1β andTNF-α, the immune indexes hs-CRP and ESR, and the pathway protein P50, P65 and IκBα were significantlyincreased in SS patients, while the salivary flow rate, break-up time of tear film, IL-4, and IL-10 decreasedsignificantly（P〈0.05 or P〈0.01）, as compared with NCgroup. Spearman analysis indicated that the indexes ofblood stasis was correlated with cytokines, NF-κBindexes, clinical signs and symptoms, and diseaseactivity indexes. After treatment, two groups ofcoagulation parameters and laboratory indexes demonstrated some improvement, especially the XFC group, which had a significantly higher efficiency and highertotal effective rate, and a better effect on reducing the levels of FIB, D-D, P50, P65, ESR, and Hs-CRP, as well asincreasing the expression of IL-1β, TNF-α and downgrading IL-4, IL-10（P〈0.05 or P〈0.01）. In conclusion, XFCcan balance cytokines production, suppress NF-κB activation in the peripheral blood of SS patients, reduce thevascular endothelial cell injury, thus to ameliorate the high blood coagulation stat